Making the Biosimilar Business Case—Exploring the Interface Between Economics and Patent Law

This first webcast of our series will explore both the economic market factors of the biosimilar world and patent strategies, and how they impact target selection for biologics and biosimilars. In contrast to the development of generic small molecules, it has been reported that it takes seven to eight years to develop a biosimilar at a cost of between $100 million and $250 million. The identification of targets requires detailed analyses of the marketplace, patent portfolios, long-term strategies for optimizing and navigating patent portfolios, and technical and regulatory issues in developing a biologic or biosimilar.

The panel will discuss factors for consideration in strategic selection and protection of biologic products, including:

• The scope of patent protection available for biologic products
• The impact of differences in patent protection in the United States and Europe
• Deciding between patent and trade secret protection
• Research, manufacturing and supply considerations, such as safe harbor protection, the ease of potential design-arounds, and potential infringement liability when a patented combination is done outside of the United States or an imported product is made by patented process performed outside of the United States
• Considerations for the use of post-grant proceedings before the United States Patent and Trademark Office and district court litigation to clear the patent thicket, including the alternative, sequential, or concurrent timing of those proceedings

This webinar is the first in Finnegan’s 2017 “Biologics and Biosimilars: The Big Picture.”

Moderator: 
Basil “Bill” J. Lewris

Speakers: 
Leslie A. McDonell 
Linda A. Wadler

Date:

Tuesday, January 24, 2017

Time:

10:00 - 11:00 a.m. PST
1:00 - 2:00 p.m. EST

Scheduling Conflict? Finnegan records all hosted webinars. To view the recorded program, simply register for the webinar and you will receive an access link shortly after the live program is complete.